George E. Yanulis
`George E. Yanulis
`M. ENG., M.S., D. ENG.
`M. ENG., M.S., D. ENG.
`216 – 571 – 1532
`216 -571 -1532
`GEORGEYANULIS55@GMAIL.COM
`GEORGEYANULIS55@GMAIL.COM
`7921 REFLECTION COVE DRIVE, APT 305| FORT MYERS, FL 33907
`7921 REFLECTION COVE DRIVE, APT 3051 FORT MYERS, FL 33907
`WWW.LINKEDIN.COM/IN/YANULIS | WWW.GYMEDICALDEVICECONSULTING.COM
`WWW.LINKEDIN.COM/IN/YANULIS 1 WWW.GYMEDICALDEVICECONSULTING.COM
`
`PROFESSIONAL ACTIVITIES
`PROFESSIONAL ACTIVITIES
`
`06/2014–Present: MEDICAL DEVICE CONSULTING LLC-President/Principal Engineer, Ft Myers, FL -
`Clinical Engineering/Medical Device Consultant Expert - including consulting on heart bypass systems
`and involved in the research & development of a heart failure therapy monitoring system
`01/2015–12/2017: Temple University - Adjunct Professor, Bioengineering Engineering Department
`03/2014–Present: B. H. Barkalow & Associates - Clinical Engineering Consultant, Newaygo, MI
`11/2010–Present: Laughlin Engineering Firm, LLC - Senior Medical Device Consultant
`08/2009–12/2013: College of Staten Island, Adjunct Faculty, Engineering and Physics Department
`
`10/2008–3/2009: Cleve Med (Cleveland Medical Devices Inc.), Consultant on a NIH design Grant related to
`ECG electrode design
`
`08/2005–08/2008: Cleveland Clinic Foundation, Doctoral Student in Applied Biomedical Engineering,
`Pre- and Post-Doctoral Associate and Research Assistant - Doctorate in Engineering, Cleveland State
`University/Cleveland Clinic, 8/2008
`
`08/2000–07/2002: University of Pittsburgh, Pittsburgh, PA Graduate Student and Research
`Assistant/Teaching Assistant - Master of Science (Bioengineering), University of Pittsburgh, 5/2002
`
`05/1999–06/2000: University of Pennsylvania Health System, Philadelphia, PA, Clinical Engineering
`Consultant
`
`08/1997–08/2000: Drexel University, Graduate Student in Biomedical Engineering and Teaching
`Assistant
`
`10/1996–05/1997: James A. Haley Veterans Hospital, Tampa, Florida Research Assistant - conducted pulse
`oximetry research under the direction of John E. Scharf, MD
`
`08/1990–08/1994: University of Alabama at Birmingham-Research Assistant & Graduate Student in
`Biomedical Engineering
`
`04/1989–08/1990: SUNY at Upstate, Syracuse, NY, Research Assistant
`
`10/1987–03/1989: Malcolm F Grow AFB, MD, USAF Active Reserves, 1st Lt & Clinical Engineer,
`Received Honorable Discharge
`
`05/1986–10/1987: RCA-Moorestown Logistics Engineer, Moorestown, NJ
`
`05/1985–05/1986: Philadelphia Naval Shipyard, US Naval Logistics Engineer
`
`
` EX1004
` Petitioner Sotera (623)
`
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`

`

`George E. Yanulis
`George E. Yanulis
`M. ENG., M.S., D. ENG.
`M. ENG., M.S., D. ENG.
`
`08/1983-3/1984: Matriculated as Osteopathic Medical Student, Chicago, IL
`
`05/1982-8/1983: US patent and Trademark Office - Assistant Patent Examiner, US Patent and Trademark
`Office
`
`2
`
`
`EDUCATION
`EDUCATION
`
`Doctorate in Engineering
`Biomedical Engineering
`
`Master of Science
`Bioengineering
`
`Master of Engineering
`Biomedical Engineering
`
`Bachelor of Arts
`Premedical Studies/Chemistry
`
`HEART FAILURE THERAPY/LVAD RESEARCH & DEVELOPMENT EXPERTISE
`HEART FAILURE THERAPY/LVAD RESEARCH & DEVELOPMENT EXPERTISE
`
`
`Cleveland State University/Cleveland Clinic
`Cleveland, OH
`
`University of Pittsburgh
`Pittsburgh, PA
`
`University of Virginia
`Charlottesville, VA
`
`Syracuse University
`Syracuse, NY
`
`
`
`2008
`
`2002
`
`1981
`
`1977
`
`
`
`Involved and continue to be involved in the R&D of ventricular assist devices and bridge
`to transplantation & destination devices for both adult and pediatric patients (2016 –
`present).
` Have and continue to be involved as a Medical Device Consultant/ Expert Witness (written
`over 30 Expert Reports and have been deposed on 6 different occasions).
` Extensive expertise in cardiac device implant and ablation device product design and
`design and execution of animal studies, including over 200 implants and 500 physiological
`monitoring studies (canine model).
` Have Performed ECG signal detection & cardiac pressure/volume analysis (canine model)
`2005 – 2008 – Cleveland Clinic Foundation
` Provided all engineering analysis and fabrication including participating in the implants in
`the OR (Cleveland Clinic Foundation– 2005-2008)
` Expert witness for a Heart Bypass System (2017- 2018)
` Reviewed Design History Files for Cardiac Perfusion Systems
` Reviewed Quality Assurance Testing and Results for atrial fibribilation (AF) therapy and
`other heart failure (HF) devices
`I have been Expert Witness on both cardiac pacemaker and implantable cardioverter-
`
`
`
`
`
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`3
`
`George E. Yanulis
`George E. Yanulis
`M. ENG., M.S., D. ENG.
`M. ENG., M.S., D. ENG.
`
`defibrillator (ICD) devices for Medtronic; St Jude Medical/Abbott; and Boston Scientific
`(BSCI) and 2 tertiary health systems (over 25 to date)
` Evaluated cardiac pacing and ICD lead/system failures
` Reviewed cardiac pacing and ICD monitoring sessions
` Expertise in the use radio frequency ablation systems for cardiac ablation therapy systems
`as a Consultant (for a health care system) and has part of my doctoral research at the
`Cleveland Clinic
` Review of materials related to BSCI cardiac ablation therapy system
` Participated in Ablation Therapy Devices/cardiac pacemaker devices being tested on the
`canine model as a doctoral student (Cleveland Clinic 2005-2009) --Doctoral Dissertation
`Link: Yanulis GE. A novel cardiac pacing paradigm for atrial fibrillation and heart failure patients
`[dissertation]. [Cleveland (OH)]: Cleveland State University; 2008 May. 106 p.
` Served as a Device Consultant for a startup venture involved in the R&D of an Ablation
`Therapy System as far as the (2018)
` Had evaluated clinical users’ needs been satisfied in view of specific end user requirements
`for US and United Kingdom medical device start-up firms, patients, and the clinician.
`
`MEDICAL DEVICE EXPERT WITNESS EXPERIENCES
`MEDICAL DEVICE EXPERT WITNESS EXPERIENCES
`
`
` Performed several Human Factors Analysis on both cardiovascular and orthopedic devices
`(2014-Present)
` Expertise in technical file review including the following for atrial ablation therapy system
`(2015); several cardiac pacemaker device cases; ICDs (2014-2016); heart bypass systems
`(2017-2018)
` Have been involved in the review of several design history files for cardiac device implants
` Evaluated design verification and validation protocols and reports for over 40 different
`medical devices (2014-Present)
` Have reviewed over 1000 MAUDE database (refer to separate attachment of selected
`devices which I have served as an Expert Witness/Medical Device Consultant (2011-
`Present)
`
`
`
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`

`4
`
`George E. Yanulis
`George E. Yanulis
`M. ENG., M.S., D. ENG.
`M. ENG., M.S., D. ENG.
`
` Have Reviewed
`Investigations, CAPA(s), Non-
`several MDR(s), Complaint
`conformance(S) and Change Control(s) for all types of cardiac device and cardiac imaging
`systems (2011-Present)
` Expertise in developing Final Evaluation Report(s) related to their current validation and
`verification tasks and provided recommendations as part of their submission to the FDA
`subsequent to an FDA site visit which had been approved by & Development and Quality
`Review Divisions at BSCI, Therakos, Inc, St. Jude/Abbott, and Medtronic (2012-Present).
`
`
`ADDITIONAL HEART FAILURE (HF) THERAPY DEVICE PATIENT EXPERTISE
`ADDITIONAL HEART FAILURE (HF) THERAPY DEVICE PATIENT EXPERTISE
` Co-Investigated the implementation of coupled pacing (CP) (a novel pacing paradigm) for
`controlling the ventricular rate of mechanical contraction (VRMC) – 2005 -2008 - Study
`Results demonstrated that acute application of CP resulted in both a negative chronotropic
`(mechanical not electrical rate) and a positive inotropic response during acutely induced
`atrial fibrillation (AF)
`https://www.annalsthoracicsurgery.org/article/S0003-4975(08)00735-2/fulltext
` Performed Preclinical Device Trials on cardiac pacing algorithms (Cleveland Clinic, 2005-
`2008)
`ADDITIONAL RESEARCH & DEVELOPMENT EXPERIENCES RELATED TO LEFT
`ADDITIONAL RESEARCH & DEVELOPMENT EXPERIENCES RELATED TO LEFT
`VENTRICULAR FUNCTION STUDIES
`VENTRICULAR FUNCTION STUDIES
`
`
` After inducing AF by rapid pacing in six dogs, we applied the following pacing modalities:
`rapid right ventricular (RV) pacing, rapid CRT, CRT with an additional RV paced beat
`(CP) at a specific delay (CRT + CP), and CRT with vagal stimulation (CRT-VS).
` Obtained Left ventricular (LV) pressure recordings and echocardiography for 2D strain
`analysis were performed. CRT + CP reduced the ventricular response rate and increased
`the LV systolic pressure and cardiac output compared with CRT alone (Cleveland Clinic,
`2005-2008).
`https://academic.oup.com/europace/article/12/3/430/476248
` Mentored and Taught over 200 undergraduate bioengineering students at Temple
`University (2015-2017) in two cardiac systems/physiology coursework in:
`o Systems Physiology- BIOE 5500
` Cardiovascular Anatomy & Physiology (materials presented)
`
`
`
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`

`George E. Yanulis
`George E. Yanulis
`M. ENG., M.S., D. ENG.
`M. ENG., M.S., D. ENG.
`
`
`5
`
` Cardiovascular Control
` Flow in cardiovascular system
`o Cardiac Devices- BIOE 4287 (materials presented)
` The Cardiac Conduction System
` Cardiac Pacing and Defibrillation
` Cardiopulmonary Bypass and Cardioplegia
` Animal Models for Cardiac Research
` Clinical Trials Formulation
` End-Stage Congestive Heart Failure: Ventricular Assist Devices
` CADs elated to the design of cardiac valves
` FDA cardiac regulated expertise
` Reviewed a Heart Bypass Template Risk Analysis and Risk Management Materials (2017-
`2018)
` Reviewed System’s Perfusion Bypass Records
` Vascular prostheses, artificial hearts/ventricular assist devices, and extracorporeal/
`intravenous oxygenators
` Expertise in biocompatibility of cardiac devices and orthopedic devices
`
`HARDWARE/SOFTWARE INTERFACE EXPERTISE/EXPERIENCES
`HARDWARE/SOFTWARE INTERFACE EXPERTISE/EXPERIENCES
`
` The Philips IntelliVue MX800 Patient Monitor for monitoring, recording, and alarming of
`multiple physiological parameters of adults, pediatrics, and neonates in hospital
`environments by trained health care professionals.
` The Philips M3001A Multi-Measurement Module (MMS)
` Echocardiographic acquisitions performed with a Vivid 7 machine (GE Healthcare)
` cSound 2.0 software beamforming technology used in Vivid 7 machine systems
` PDP 11 assembly programming
` Collaborated with Data Science Corporation (DSI) on several projects that included
`advanced ECG signal detection and pressure-volume loop analysis (Cleveland Clinic 2018-
`2009)
` Expertise in the R&D of Positron-emission tomography (PET) generators and PET
`imaging systems, Radio frequency ablation and mapping systems
`
`
`
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`6
`
`George E. Yanulis
`George E. Yanulis
`M. ENG., M.S., D. ENG.
`M. ENG., M.S., D. ENG.
`
` Expertise in Image Reconstruction Techniques for Computerized Tomographic (CT)
`Coronary Artery Calcium Quantification, Reconstruction methods used in helical and
`multi-slice CT
` Expertise in Fourier Analysis of Discrete-Time Signals – Fast-Fourier Transform and
`Discrete Filter Design, Sampling and Discrete-Time Signal Analysis
` Continuous Time Signal and Non-Continuous Time Signal Analysis
`
`IMAGING SYSTEMS RELATED COUSEWORK TAKEN
`IMAGING SYSTEMS RELATED COUSEWORK TAKEN
`
` 
`
` Biomedical Signal Processing
` Computation and Modeling in Biomedical Engineering
` Cardiovascular systems and dynamic modeling
` Computer applications/techniques used in medicine
`
`IMAGING SYSTEMS & CARDIAC DEVICE COUSE WORK TAUGHT (TEMPLE UNIVERSITY –
`IMAGING SYSTEMS & CARDIAC DEVICE COUSE WORK TAUGHT (TEMPLE UNIVERSITY -
`2015-2017
`2015-2017
`
`
` Biomedical Signal Processing
` Cardiac Systems Course
`
`MEDICAL DEVICE EXPERT WITNESS EXPERIENCES INTELLECTUAL PROPERTY
`MEDICAL DEVICE EXPERT WITNESS EXPERIENCES INTELLECTUAL PROPERTY
`EXPERTISE
`EXPERTISE
`
`
`
`
`
`
`I have written Three (3) Invalidity Reports and Two Infringement Analysis Reports for two
`medical devices.
`I have been employed as an Assistant Patent Examiner at the U.S. Patent and Trademark
`Office. In that capacity, I examined patent applications for potential novel applications in
`the medical infusion and sharp systems area for such applicants as Baxter Travenol
`Laboratories, Abbott Labs, and other patent applicants (1982-1983). I was enrolled in the
`USPTO’s Patent Examiner’s Training Program and received the USPTO’s Superior
`Achievement Award (May, 1983).
`
`
`DEPOSITIONS GIVEN BY DR. GEORGE YANULIS AS OF 4/27/2020
`DEPOSITIONS GIVEN BY DR. GEORGE YANULIS AS OF 4/27/2020
`
`
`Case Name
`Hitachi Medical Systems v.
`South West Mississippi
`Anesthesia, P.A.
`
`Court
`United States District
`Court Middle District
`of Louisiana Civil
`
`Date Filed
`July 31, 2013
`
`
`
`Party Affiliation
`South West Mississippi
`Anesthesia, P.A.
`
`
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`

`George E. Yanulis
`George E. Yanulis
`M. ENG., M.S., D. ENG.
`M. ENG., M.S., D. ENG.
`
`
`7
`
`
`
`April 25, 2014
`
`Robert Bowie and
`Susan Bowie
`
`October 8, 2013
`
`Thomas Ruxlow
`
`Dec 27, 2013
`
`George Koulas
`
`October 30, 2014
`
`Theotis Latimore
`
`Action No. 12-
`273BAJ-SCR
`Superior Court of
`Maine Androscoggin
`County Civil Action
`No. CV2014-74
`United States District
`Court Southern
`District of Iowa
`Central Division Civil
`Action 4:13-CV-428
`United States District
`Court District of
`Hawaii Civil No. 13-
`00713 BMK
`STATE OF
`MICHIGAN IN THE
`CIRCUIT COURT
`FOR THE COUNTY
`OF OAKLAND
`
`
`Case No. 14-138209-
`NH
`
`Robert Bowie and Susan
`Bowie v. Arthrex, Inc. and
`Surgical Systems, Inc.
`
`Thomas R. Ruxlow v.
`DuPuy Orthopedics, Inc.
`and Johnson & Johnson
`
`George Koulas v. DuPuy
`Orthopedics, Inc
`
`Theotis Latimore v.
`Botsford Hospital, John
`Parmely, D.O., John
`Parmely, D.O., P.C.,
`Specialist in General
`Surgery, Harun Zekirovski,
`D.O, Covidien LP and/or
`Covidien PLC, formerly
`known as Covidien LTD,
`and Medtronic, Inc.,
`successor corp.
`Jake Lovato, Individually
`Lovato and as Personal
`Representative of the
`Wrongful Death Estate of
`Altagracia Gloria Lovato
`(Plaintiffs),
`
`
`vs.
`
`
`Board of Regents of the
`University of New Mexico
`Board of regents of The
`University of New Mexico,
`Defendants.
`
`First Judicial District
`Court County of Santa
`Fe State of New
`Mexico No. D-101-
`CV-201301167
`
`April 24, 2013
`
`Board of Regents of the
`University of New
`Mexico
`
`
`PUBLICATIONS (PEER REVIEW PUBLICATIONS)
`PUBLICATIONS (PEER REVIEW PUBLICATIONS)
`
`Lim P, Yanulis GE, Verhaert D, Greenberg NL, Grimm RA, Tchou PJ, Lellouche N, Wallick DW.
`Coupled pacing improves left ventricular function during simulated atrial fibrillation without mechanical
`dyssynchrony. Europace. 2010 Mar;12(3):430-6. doi: 10.1093/europace/eup440
`
`Yanulis GE, Lim P, Ahmad A, Popović ZB, Wallick DW. Coupled pacing reverses the effects of
`persistent atrial fibrillation on the left ventricle. Ann Thorac Surg. 2008 Sep;86(3):984-7. doi:
`10.1016/j.athoracsur.2008.03.085
`
`
`
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`

`

`George E. Yanulis
`George E. Yanulis
`M. ENG., M.S., D. ENG.
`M. ENG., M.S., D. EN G.
`
`8
`
`Yanulis GE. A novel cardiac pacing paradigm for atrial fibrillation and heart failure patients
`[dissertation]. [Cleveland (OH)]: Cleveland State University; 2008 May, 106 p.
`Cingoz F, Yanulis GE, Ching E, Fukamachi K, Wallick DW. Use of conventional dual chamber
`pacemakers with custom lead adapters to induce atrial fibrillation or heart failure in dogs. Ann Thorac
`Surg. 2007 May;83(5):1858-62.
`
`ABSTRACTS
`ABSTRACTS
`— Two abstracts presented on heart failure research at American College of Cardiology meeting
` March 2008
`
`PRESENTATIONS
`PRESENTATIONS
`
`— Rutgers Medical School, Cardiology Department
` March 2013
`— Rutgers College of Engineering, Biomedical Engineering
` 2012
`— Cleveland State University
` April 2008
`
`HONORS / AWARDS
`HONORS / AWARDS
`
`— Cleveland Clinic Research Innovation Award
` September 2008
`— Cleveland Clinic Research Innovation Award
` October 2007
`— Honorable Discharge, USAF Medical Service Corp, 1st
` March 1989
`— Superior Achievement Award, United States Patent Office
` 1983
`— Member of Tau Beta Pi Engineering Honorary
`PROFESSIONAL AFFILIATIONS / SOCIETIES
`PROFESSIONAL AFFILIATIONS / SOCIETIES
`
`— Association for the Advancement of Medical Instrumentation
`— Heart Rhythm Society
`— IEEE Engineering in Medicine & Biology
`
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`